Research Associate, Community Oncology Research Program, part-time

Overview

JOB SUMMARY

This position is within the Wake Forest NCI Community Oncology Research Program (NCORP) Research Base. The Research Associate is a non-faculty employee. With investigators, direct and coordinate various aspects of the NCORP grant which includes planning, implementation, evaluation and dissemination. Use of judgement and discretion in performing assigned duties and responsibilities related to the grant are necessary. This is a part-time, 20 hrs/week position.

EDUCATION/EXPERIENCE

Master's degree or comparable graduate degree, with at least eight (8) years of relevant research experience; OR equivalent combination of education and experience.

ESSENTIAL FUNCTIONS

1. Work with the Grant Administrator, Principal Investigators or Co-Principal Investigators to plan and/or design studies/projects. Manages new assigned projects, including the development and operations of new studies that Wake Forest NCORP Research Base has elected to be a coordinating center.
2. Responsible for study development and activation procedures, including protocol, consent, and data form development; determines the operations of the project; develops SOPs and other logistically documents to assist sites and study team in the completion of the project; regulatory submission to NCI-CIRB and FDA (if needed), work with NCORP regulatory group, sites and CIRB to address any regulatory concerns/issues throughout the life of the study.
3. Coordinate with the site coordinator, regulatory group, database developer, statisticians, NCI, study sponsor, study team and/or other institutional departments to ensure that all aspects of new studies are complete and ready for activation within the project timeline. Continues to function in a consultant role throughout the study for any problems or issues.
4. Identify areas for process improvements; assists with the improvement activities; ensure high quality operations and coordinates training of new study staff; develops and maintains standard and administrative operating procedures.
5. Assists NCORP Administrator, when needed, with the following: Oversee financial budgeting, analysis and resource allocation; work with sponsors to negotiate adequate compensation for clinical and/or other study related activities; review budgets monthly to determine correct sponsor payments and reconcile any discrepancies; establish a separate billing file on specific accounts related to individual departments/sections during the course of a project; approve grant expenditures.
6. Participate in site audits, following NCI requirements and guidelines. Assist other auditors, as needed with audit preparation. Educate sites on NCORP protocols, policies and procedures, if applicable. Promote upcoming and current NCORP studies.
7. Collaborate with NCORP Site Coordinators with the following: develop and implement key reporting requirements; participates in site calls/visits and monitor/report on key metrics to PI and Co-PI; makes appropriate strategic decisions to prioritize, operationalize and drive performance; will be a subject matter expert to expedite and improve study procedures, timeliness and workflows. Analyze program outcomes.
8. Collaborate with NCORP Data Management and Quality, as needed, with pending questions, or data clean-up, especially as studies end.
9. Collaborate with NCORP Regulatory group with protocol amendments, regulatory issues and site regulatory questions.
10. Review journals, abstracts and scientific literature to keep abreast of new developments in assigned therapeutic area. Assist PIs and Co-PI in the development of publications, and other research documents, such as grants, abstracts, policies, etc.
11. Prepares grants and other funding proposals with limited supervision. Collects, analyzes, and presents data readily for publications. Compiles and writes scientific progress reports and evaluations. Assists in writing progress reports.
12. Ensure that all requirements of the Medical School and the University are complied with, relative to the conduct of the study; ensure that all technical requirements of the funding agency and NCORP are met, including auditing requirements.
13. Represent the project to all relevant agencies and organizations, serving as a study liaison, spokesperson, and representative, as needed. 
14. Perform other related duties incidental to the work described herein.

SKILLS & QUALIFICATIONS

• Good interpersonal and communication skills (verbal, non-verbal & listening)
• Basic computer skills
• Flexibility in work schedule
• Experience with regulatory activities for multisite trials
• Presentation skills

WORK ENVIRONMENT

• Subject to interruptions
• Subject to irregular work hours